{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "192783", "product_res_number": "Z-1054-2022", "event_date_initiated": "2022-04-01", "event_date_created": "2022-05-10", "recall_status": "Open, Classified", "res_event_number": "89881", "product_code": "EOB", "k_numbers": [ "K171402" ], "product_description": "11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)", "code_info": "11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)\nUDI Code: 0408551225608\n\nAll Serial Numbers manufactured/distributed since January 2018", "firm_fei_number": "3007475226", "recalling_firm": "Karl Storz Endoscopy", "address_1": "2151 E Grand Ave", "city": "El Segundo", "state": "CA", "postal_code": "90245-5017", "additional_info_contact": "888-352-9616", "reason_for_recall": "Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.", "root_cause_description": "Under Investigation by firm", "action": "On 04/01 and 6/2022, the firm emailed an \"Urgent Medical Device Recall\" letter to customers and followed up with a hardcopy letter on 04/07-08/2022 via their Third Party contractor informing customers of a labeling update to correct the instructions for use for certain flexible urological endoscopes and advise that high-level disinfection should not be used as a method of reprocessing. Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA was performed. Testing showed that the required efficacy level of disinfection using CIDEX OPA was not achieved. To the extent included in the current applicable instructions for use, the following methods are being removed as reprocessing methods from the instructions for use of the affected endoscopes. +Manual High-Level Disinfection: -Cidex-OPA -Revital-Ox\" RESERT (e.g., 2.0% Accelerated Hydrogen Peroxide solution). +Automated Endoscope Reprocessor: -Medivators AER -Reliance EPS -EvoTech ECR Customer Actions: 1. Immediately discontinue the use of all high-level disinfection methods for reprocessing the affected endoscopes. 2. The affected endoscopes should be sterilized after each use by one of the sterilization methods recommended in the instructions for use specific to each endoscope. 3. If your facility does not have access to a sterilization method recommended in the applicable instructions for use, immediately discontinue use of the affected endoscopes and return products to KARL STORZ. 4. Ensure that all relevant personnel in your organization are aware of recall. 5. Updated instructions for use will be available at https://spwebspace.karlstorz.com/sites/HLDCorrection/SitePages/Home.aspx . Once the updated instructions for use are available, discard any prior versions of the instructions for use. Any questions: Telephone: 1-888-352-9616 Fax: 1-888-912-7088 E-Mail: karlstorz7041@sedgwick.com", "product_quantity": "All Serial Numbers manufactured/distributed since January 2018", "distribution_pattern": "U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.", "openfda": { "k_number": [ "K192305", "K942265", "K954348", "K052452", "K963426", "K202727", "K954336", "K100577", "K944861", "K132009", "K252050", "K960876", "K132433", "K950603", "K100125", "K152531", "K946011", "K243380", "K992526", "K131323", "K002214", "K990354", "K161298", "K991560", "K070580", "K072073", "K230536", "K962898", "K882744", "K981751", "K902683", "K253184", "K261544", "K951196", "K031790", "K082667", "K192090", "K950809", "K023004", "K896297", "K972855", "K243639", "K951201", "K962255", "K984369", "K962396", "K171402", "K961591", "K221638", "K953888", "K940317", "K200609", "K972450", "K234096", "K142249", "K963757", "K232015", "K032822", "K013591", 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